Bayer on track to file prostate cancer drug in 2012

Updated results from a phase III trial of Bayer's bone metastasis treatment Alpharadin have confirmed the drug's benefit on survival in prostate cancer patients, putting the company on track to file for marketing approvals later this year.

Alpharadin (radium-223 chloride) is a radiopharmaceutical originally developed by Norwegian pharma company Algeta and licensed on an exclusive, worldwide basis by Bayer in 2009.

It is designed to treat advanced cases of cancer in which the disease has spread to the bones by delivering small doses of targeted radiotherapy to the secondary tumours.

Last year, Bayer and Algeta halted the phase III ALSYMPCA trial after an analysis of interim data found a three-month survival advantage in patients treated with the drug compared to those on placebo, described at the time as a finding that could change medical practice.

The updated analysis of the 921-patient study confirmed the overall efficacy results of the interim analysis, showing an increase in median overall survival of 3.6 months (14.9 months in the Alpharadin arm versus 11.3 months for placebo).

"This analysis of the updated ALSYMPCA data confirms the positive results we have previously seen with Alpharadin in improving survival in castration-resistant prostate cancer patients with bone metastases," said Gillies O'Bryan-Tear, Algeta's chief medical officer.

Analysts have suggested that if approved, sales of the drug could top $650m a year by 2015, which would be a major success for Algeta with its first-ever drug candidate.

Meanwhile, development continues in other indications. Towards the end of last year Algeta also reported the results of a phase IIa trial of Alpharadin in endocrine-refractory breast cancer patients with bone metastases.

The study found that the radiopharmaceutical met the two primary endpoints of significantly reducing levels of bone alkaline phosphatase (bALP), and urine N-telopeptide (uNTX) over a 16-week treatment period.